Impact of changes in the rules of Registration of medicines by the EAEU on the regulation of the turnover of medicines on its territory

To perform the urgent tasks of optimizing the procedures for registration of medicines within the framework of the Eurasian Economic Union, it is necessary to analyze and evaluate the current changes made to the Rules for Registration and Examination of Medicines after approval by the Eurasian Economic Commission. The purpose of this paper was to conduct an expert assessment of the main changes made to the Eurasian Economic Commission Rules over the 2022-2023. The assessment was carried out by 38 experts with experience in communication with regulatory bodies on the registration of medicines and making changes to the registration dossier, according to the Likert scale using the developed expert assessment card. It has been established that, in general, experts have a positive attitude to the changes both from the standpoint of their practical significance and the optimal balance of stability and flexibility and in terms of accuracy, correctness, and clarity of formulations. Attention is drawn to the insufficient accuracy of some concepts and to the need to reflect all new terms in section II of the Eurasian Economic Commission Rules. The experts have specifically noted the creation of the necessary conditions for the active circulation of orphan medicines, their accelerated use in some individual cases, increasing the availability of unregistered medicines in special cases, ensuring the possibility of obtaining an indefinite registration certificate, and providing a registration dossier only on electronic media,excluding the annual revaluation of the benefit/risk ratio for some medicines, and the acceleration of the mutual recognition procedures in several EAEU member states due to simultaneous initiation. It has been shown that there is a need for a more detailed consideration of changes in the timing of registration and examination procedures for medicines, as well as in the analysis and evaluation of changes in the annexes to the Eurasian Economic Commission Rules. The use of the change management methodology would allow for more consistent and efficient management of amendments to the Eurasian Economic Commission Rules.